Senior Director, CMC Regulatory

Kardigan; South San Francisco (CA); On-site; USD 248,000 - 310,000; Full time

Job summary

Kardigan seeks a Senior Director, CMC Regulatory to lead the development and execution of CMC regulatory strategies driving global submissions and interactions with health authorities. This role reports to the Head of CMC Regulatory and is based in South San Francisco, onsite four days a week.

The ideal candidate has a scientific degree with 10+ years in regulatory affairs, strong FDA/EMA/ICH knowledge, and experience with IND/IMPD and NDA/MAA submissions, preferably in small molecules.

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• 10+ years in CMC Regulatory Affairs.
• Experience with IND/IMPD and NDA/MAA submissions.
• Strong knowledge of FDA/EMA/ICH guidelines.
• Small molecule experience preferred.

Responsibilities

• Lead development and execution of CMC regulatory strategies.
• Manage regulatory CMC aspects for global submissions.
• Coordinate health authority interactions with agencies.
• Ensure compliance with global CMC requirements and guidelines.
• Develop and implement department practices, SOPs and processes.
• Manage internal or external staff as needed.

Skills

CMC regulatory strategies

Regulatory submissions

Health Authority interactions

Cross-functional collaboration

Staff management

Education

Bachelor’s degree in scientific discipline

Advanced degree in Chemistry

Job description

About Us

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.

It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases closer to the cures they deserve.

Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.

We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.

At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.

These values are the foundation of our work, empowering us to make a real difference, every day.

Position Title: Senior Director, CMC Regulatory

Department: Regulatory Affairs

Reports To: Head of CMC Regulatory

Location: South San Francisco, CA (onsite 4 days per week)

Job Overview

Kardigan is seeking a Senior Director, CMC Regulatory to support Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases closer to the cures they deserve. The Senior Director will be responsible for leading CMC Regulatory activities to help advance Kardigan’s late-stage clinical assets through clinical development and towards marketing approval. We are looking for a highly motivated individual who will help define CMC Regulatory strategies and successfully execute them in submissions and health authority interactions, in close collaboration with cross-functional partners. This position will report to the Head of CMC Regulatory.

Essential Duties And Responsibilities

• Lead the development and execution of CMC regulatory strategies, working in close collaboration with cross-functional teams to ensure regulatory strategies are aligned with program objectives and timelines
• Proactively manage regulatory CMC aspects of programs to ensure on-time delivery of global, high-quality submissions across all development-stage programs
• Manage regulatory interactions with global health authorities, including meeting preparation and participation, responses to questions, and negotiations.
• Provide regulatory expertise on CMC strategies to cross-functional teams, anticipating regulatory concerns, and proposing innovative solutions.
• Ensure compliance with relevant global CMC requirements (FDA, EMA, and ICH guidelines), and proactively monitor regulatory trends, guidance documents and changes to existing regulations.
• Evaluates proposed manufacturing and quality changes for impact to ongoing and existing submissions and provides strategic regulatory guidance for optimal implementation of changes.
• Help develop and implement department practices, policies, processes, and SOPs
• Manage internal or external staff as needed

Qualifications And Preferred Skills

• Bachelor’s degree in scientific discipline required, advanced degree in Chemistry preferred
• Minimum of 10 years industry experience with majority of experience in CMC Regulatory Affairs or related roles
• Experience with global early and late phase submissions (IND/IMPD and NDA/MAA, amendments, and annual reports) and health authority interactions
• Prior small molecule experience preferred
• Excellent knowledge of FDA, EMA and ICH regulatory guidelines and regulations
• Collaborate and communicate well with all levels of employees, including peers, executives and cross-functionally
• Strong interpersonal, communication (oral and written), and organizational skills
• Ability to handle and prioritize multiple assignments, and work in a fast-paced environment.

Exact Compensation may vary based on skills, experience and location.

Pay range $248,000 - $310,000 USD